Case Safety Report Transmission Guide

FDA has published a technical specifications document, FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products, to assist submitters in transmitting electronic individual case safety reports and attachments to the FDA Adverse Event Reporting System (FAERS) database. The document describes the agency’s technical approach for submitting individual case safety reports, for incorporating its regionally controlled terminology, and for adding FAERS regional data elements that are not addressed in the electronic transmission document for specified FDA-regulated products.

The implementation guide says FDA adopted the International Council for Harmonization Implementation Guide for Electronic Transmission of Individual Case Safety Reports: E2B(R3) Data Elements and Messaging Specifications in 2/2014.